Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
FKG · Predicate Candidate Screening
6 FDA 510(k) clearances under this product code; the 50 most recent screened below.
104 daysmedian FDA review time
916 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K925469 | JJ SKINNER CAREKITS(TM) DIALYSIS ON/OFF KIT | J.J. Skinner, Inc. | 1995-05-03 | 916 | 0 |
| K871630 | KITS AND TRAYS FOR DIALYSIS USE | Dove Medical Supplies | 1987-05-26 | 29 | 0 |
| K833780 | CAPD PREP KIT | Professional Dialysis Products | 1984-02-09 | 104 | 0 |
| K802361 | DIALYIS START CARE KIT | Med-Pak Corp. | 1981-01-16 | 112 | 0 |
| K792207 | PERIDIAL PERITONEAL DIALYSIS TRAY | Cutter Laboratories, Inc. | 1979-12-10 | 38 | 0 |
| K790353 | ACUTE RENAL DIALYSIS TRAY | Argon Medical Corp. | 1979-04-20 | 57 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda